Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: A randomized, phase 3, double-blind, placebo-controlled trial
The Lancet Jul 18, 2019
Croop R, et al. - Via a double-blind, randomized, placebo-controlled, multicenter phase 3 trial, researchers assessed the effectiveness, safety, and tolerability of a novel orally disintegrating tablet formulation of rimegepant, (a small molecule calcitonin gene-related peptide receptor antagonist) at 75 mg vs placebo in the acute treatment of migraine. A total of 1,466 subjects aged 18 years or older with a history of migraine of at least 1 year enrolled to 69 study centers in the US between February 27 and August 28, 2018 were randomized to rimegepant (n=732) or placebo (n=734), of whom 1,375 received treatment with rimegepant (n=682) or placebo (n=693), and 1,351 were assessed for effectiveness (rimegepant n=669, placebo n=682). The rimegepant orally disintegrating tablet was found to be better than placebo for freedom from pain and freedom from the most bothersome symptom at 2 hours postdose. Nausea and urinary tract infection were the most common adverse events. No severe adverse events were reported by treated individuals. A single 75 mg dose of rimegepant in this formulation was more effective vs placebo, in the acute treatment of migraine, with no safety concerns, and tolerability was the same as the placebo.
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